Micronutrients are elements or compounds which are present in foods in small or trace amounts and includes vitamins, minerals or other elements; and compounds found in foods for which a Recommended Dietary Allowance (RDA) has not yet been determined (pantothenic acid, biotin, choline, etc.). The macronutrients consist of carbohydrates, fats and proteins which supply nutrients and calories. Some elements such as calcium, sodium, potassium, chloride and phosphorus are elements consumed in relatively large amounts, while many such as iron, iodine, and zinc are consumed in small amounts (milligrams). Vitamins such as vitamin B12, and folic acid and the minerals copper, selenium and chromium are consumed in very small, or trace amounts (micrograms). Inasmuch as the human body, does not synthesize many "essential compounds", these specific vitamins and minerals can be obtained from only two sources: foods and supplements. The primary source of all nutrients is food. Over the past four decades, ample evidence documents that major portions of various subgroups of Americans stratified by age, gender, socioeconomic status and other variables, cannot meet the "Recommended Dietary Allowances" of the foods containing these essential compounds and elements. Thus vitamin and mineral supplementation has become a recognized method of meeting accepted medical and public health nutrition standards. The enrichment of bread with iron and B vitamins in 1940 is considered a major factor in assuring favorable nutritional status for the general population of that time, and has been retained as a major advance for public health. In 1993, the Interagency Board of Nutrition Monitoring and Related Research reported that women did not meet the RDA's of 6 out of 15 micronutrients: B6, E, calcium, iron, magnesium and zinc. Men also failed to met the RDA's for 4 of 15 micronutrients: B6, E, magnesium and zinc. Their findings reveal significant prevalence and incidence of various population subgroups deficient in specific vitamins and minerals. The importance of these findings relate to the prevention of micronutrient deficiency diseases such as scurvy (vitamin C deficiency), pellagra (niacin deficiency), beri-beri (vitamin B1 deficiency), iron deficiency anemia and other vitamin and mineral deficiency states. The effect of marginal deficiency states is only now being considered as a cause of suboptimal health status. Moreover, research conducted and published in the past three decades indicates that antioxidant micronutrients are involved in preventing molecular biological processes affecting health and disease at the subcellular and submolecular level. It is current thought that free-radical effects on cells and tissues can be modified by antioxidant micronutrients reducing cellular damage. Specific micronutrients maintain immune system integrity, moderate the aging process, and play a role in the prevention of atherogenesis and cancer.
Furthermore, substantial segments of the population do not manifest desirable eating patterns, that is, an adequate intake in both the quantity and variety of food to fulfill the Recommended Dietary Allowances, as indicated by recent government survey. Only 22% of the subjects of a National Cancer Institute Study, consumed the recommended number of dietary servings of fruits and vegetables.
Lifestyle factors such as smoking, levels of physical activity, exposure to toxic environmental compounds, dieting, use of certain medications such as oral contraceptives, and the avoidance of certain foods (for example, due to lactose intolerance which occurs in over 25% of the population), can also contribute to low or deficient intakes of nutrients.
It has been further documented that the American public is unaware of the importance of public health nutrition recommendations. Only 8% of adults eat the recommended number of daily servings of fruits and vegetables. Micronutrient deficient states may be recognized by physicians, nutritionists and dietitians who are trained in clinical nutrition. However, the physical findings of a nutritional deficiency can be subtle, and physicians may not be trained in detecting them. The use of laboratory methods to assess nutritional status, which includes blood and tissue levels of vitamins and their effects (A, C, E, D, etc.) on various enzyme systems (B1, B2, B6), is often considered the most reliable method of assessing nutritional status, though these special testing procedures are expensive and do not exist in standard medical offices or in many hospital clinical laboratories. Thus the invention of an easily accessible formulation which supplies nutrients that help prevent the most commonly seen deficiencies would benefit the public.
In the last decade it has also been determined that "marginal" vitamin and mineral deficiency states occur, in which the blood or tissue levels are in the "low" range, without the presence of physical signs of deficiency, but which may induce symptoms of fatigue, lassitude, and a general sense of ill health. It is thus clear that nutrition science has progressed in defining its role in health, and that the role micronutrients play in health and in disease prevention is indeed substantial and gratifying.
However, because of the special training required for qualified and certified nutrition assessments, the expenses involved, and the time required to conduct the necessary history taking, physical examination and appropriate laboratory testing, it is apparent that consumers are forced into making their own nutrient supplement choices. Currently there are a plethora of over-the-counter vitamin and mineral supplements which fail to completely consider the extensive nutrition science literature. These are based on a "shot-gun" approach of supplying 100% of the Recommended Dietary Allowances for some of the micronutrients for which an (RDA) exists, fail to consider the consumer's dietary contribution of vitamins and minerals, and often provide unproven ingredients, inadequate dosages of important nutrients, and megadoses without a scientific rationale.
The multi-vitamin formulations available heretofore are designed without consideration for micronutrient interactions. Examples of the significance of these reactions is the required presence of optimal vitamin C for the absorption of iron, the presence of Vitamin D for the absorption of calcium, and the mutually protective effects of vitamin A and E. Another problem is that many of the multi-vitamin formulations today do not take into account the different dietary allowances and needs for men and women. In addition, most multi-vitamin formulations currently available require once-daily dosing which do not take into consideration loss of water soluble nutrients which are not well stored by the body and are utilized in energy-yielding reactions during the day. Moreover, many multi-vitamin formulations on the market are haphazardly self-designed to supply megadoses of potentially toxic amounts of nutrients, such as vitamin A, vitamin D, vitamin B6, iron, zinc and copper. Other commercially available vitamin formulations contain unnecessary and potentially allergic compounds, such as dyes, fillers and sugars like lactose.
Public health nutrition can be considered a "two-edged sword." One edge represents nutritional deficiencies such as protein-energy, malnutrition, the hypovitaminoses, nutritional anemias, osteoporosis, iodine deficiency and other specific deficiencies. The other "edge" are the nutritional excesses and determinants of major diseases. These excesses include calories, saturated fats, total fat, dietary cholesterol, sodium, and alcohol, as well as insufficient dietary fiber, potassium, iron and antioxidant micronutrients (Vitamins A, C, E, selenium, zinc, carotenoids etc.).
Many Americans get less than 70% of the recommended daily allowances for many nutrients. The public health importance of older populations is emphasized by a World Health Organization report indicating that by the year 2000 those over 60 will reach 17% of the total population.
Moreover, the work of experimental and clinical pathologists have identified the histological and subcellular changes which take place to induce atherosclerosis in experimental animals and man. The emerging concept is that oxidized low density lipoprotein (LDL) is the key initiating agent in atherogenesis, since contrary to normal LDL, oxidized LDL is rapidly attacked by scavenging receptor macrophages which, in turn, incite the production of lipidladen foam cells. These cells comprise the "fatty streak," which is the first macro tissue change in arterial endothelium and intima. The effect of the oxidized LDL is cytotix to endothelial cells. It causes increased cell membrane permeability, which allows more oxidized LDL to enter the cells, increases the permeability of endothelial cells which thus makes them pervious to nicotine, and norepinephrine release due to psychological stress, and other noxious compounds which increase the risk of coronary heart disease. These findings assumed new significance when it was discovered that the oxidation of LDL could be prevented significantly by micronutrient antioxidants such as beta carotene and vitamin E.
The original concept that nutrients could effect biological and physiological systems began with the study of the aging process. Intracellular oxidative reactions in brain cells were found to play a major role in the aging process. Animal and human studies gave further impetus to these findings when it was shown that specific micronutrients, notably vitamin E, substantially blocked the induction of free radicals. Later, it was documented that lipid peroxidation formed free radicals with release of free-spinning electrons which injured delicate subcellular organelle structures such as mitochodrial membrances. This, in turn, caused release of enzymes and other toxic compounds into the cytisol which induces further injury. As related to atherogenesis, both oxidized LDL and peroxidation of fatty acids are now considered to induce macrophage and other cells to transform into foam cells which comprise the fatty streak, the earliest histologically detectable origins of coronary atherosclerosis, as cited above.
The atheroscelrotic plaque forms when there is proliferation of foam cells, invasion of the histological environment with calcium, and distortion of the normal cellular architecture of the coronary artery. Moreover, the normal endothelial cell is also injured in this process, and the once smooth internal surface of the artery now becomes roughened. It is upon this surface that platelets can become adherent, and aggregate to initiate the formation of a thrombus. When the plaque is hardened, an edge of it may break away from the endothelium to which it adheres. This makes it open to the shearing effect of blood, to which more platelet aggregation can cause the clot to enlarge and thus further restrict the arterial flow; or in some instances the shearing effect of blood can "dissect out" the plaque and convert it to an embolus blocking the artery. Both events can result in myocardial infarction.
Consequently, there still exists a need for a nutritional system which supplies the right amount of the right micronutrients at the right time to help prevent the problems commonly seen with vitamin supplementation available today and to assure adequate intake of micronutrients needed for disease prevention and protection against nutritional losses and deficiencies due to, for example, lifestyle factors and common inadequate dietary patterns.